Sr. Clinical Trial Associate

Role: Senior Clinical Trial Associate supporting clinical operations for Summit’s oncology Phase 3 studies in NSCLC and colorectal cancer, with an investigational therapy (ivonescimab). Objectives include providing administrative support across study activities to ensure smooth trial execution. Responsibilities encompass managing meeting logistics, document filing, study tracker maintenance, oversight of eTMF and vendor interactions, and supporting study start-up and close-out processes. They also assist with study budgeting, compliance, and cross-functional coordination. Qualifications include a bachelor's in biological, health sciences, or related field; 4+ years of experience in clinical study environments within CROs or pharma; proficiency with CTMS and eTMF systems; and knowledge of GCP, FDA regulations, and clinical trial processes from start-up to close-out. Preferred skills involve strong organizational, communication, and problem-solving abilities, with attention to detail and confidentiality. High-value specifics include supporting Phase 3 oncology studies for NSCLC and colorectal cancer, with a focus on regulatory compliance, document management, and vendor oversight. The role is based in a hybrid setup, with no travel specified.